Healthy Japanese
Conditions
Interventions
Intake of 100 mg of the test food for 4 weeks
Intake of 300 mg of the test food for 4 weeks
Intake of the placebo food for 4 weeks
Sponsors
Pharma Foods International Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Female aged 40 to 64 years 3. Healthy individuals 4. Individuals with a SMI total score between 26 and 50 5. Individuals who perceive temporary hot flashes
Exclusion criteria
Exclusion criteria: 1. Diagnosed with or suspected of menopausal/climacteric disorder by a physician 2. History or presence of serious diseases (e.g., malignant tumor, heart failure, or myocardial infarction) 3. Use of a pacemaker or implantable cardioverter defibrillator (ICD) 4. History or presence of chronic diseases (e.g., cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia,hypertension, or any other chronic diseases) 5. Habitual use of health foods, dietary supplements (e.g., GABA, equol, or soy isoflavones), or medications (e.g., Kampo medicines such as Keishibukuryogan or Kamishoyosan) that may affect menopausal symptoms 6. Allergic to medicines or ingredients related to the test product 7. BMI < 18.5 kg/m2 or >= 25.0 kg/m2 8. Heavy drinkers (average pure alcohol intake >= 60 g/day) 9. Excessive caffeine intake ( >= 500 mg/day) 10. Heavy smokers ( >= 20 cigarettes/ day or Brinkman Index >=400) 11. Extremely irregular lifestyle rhythms due to night shifts, shift work, or other reasons 12. Undergoing exercise or alimentary therapy under medical supervision 13. History or presence of drug or alcohol dependence 14. History or presence of psychiatric/sleep disorders (e.g., depression, insomnia, sleep apnea syndrome) 15. Pregnant, lactating, or planning to become pregnant during this study 16. Enrolled in other clinical trials within 28 days prior to consent, or planning to participate in another study 17. Judged ineligible to participate in this study based on measurement values at screening 18. Judged ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Actual values in the SMI (Simplified Menopausal Index) total score at 4 weeks after the start of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in the SMI total score at 4 weeks after the start of intervention. 2. Actual values and change from baseline in hot flash Visual Analogue Scale (VAS) scores at 4 weeks after the start of intervention. 3. Actual values and change from baseline in each of the 10 item scores of the SMI at 4 weeks after the start of intervention. Items include:(1) hot flashes, (2) sweating, (3) coldness in extremities, (4) palpitations, (5) insomnia, (6) irritability, (7) depression, (8) headaches/dizziness, (9) fatigue, and (10) joint/muscle pain. 4. Composite hot flash score from baseline to week 4 of the intervention. 5. Actual values and change from baseline in the PSQI-j (Japanese version of the Pittsburgh Sleep Quality Index) global score and its 7 component scores at 4 weeks after the start of intervention. Components include:(1) sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. 6. Actual values and change from baseline in the POMS 2 (Profile of Mood States 2nd Edition) adult short form TMD score and its 7 subscale scores at 4 weeks after the start of intervention. Subscales include:(1) Anger-Hostility, (2) Confusion-Bewilderment, (3) Depression-Dejection, (4) Fatigue-Inertia, (5) Tension-Anxiety, (6) Vigor-Activity, and (7) Friendliness. | — |
Countries
Japan
Contacts
Public ContactHiroyuki Miyazawa
HUMA R&D CORP Clinical Development Department
Outcome results
None listed